Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms)
Conditions
Keywords
BPH, LUTS, water vapor thermal ablation, minimally invasive treatment
Brief summary
Rezūm is a minimally invasive procedure that uses water vapor (steam) to treat urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia, BPH). It has been used in clinical practice since receiving FDA approval in 2015 and is recommended as a treatment option for men with moderate-to-severe urinary symptoms, including those who wish to preserve ejaculatory function. Clinical trials have shown that Rezūm improves urinary symptoms and flow rates, with benefits that last for at least five years, a low reoperation rate, and a low risk of sexual side effects. Despite this evidence, several important questions remain. It is not well understood which patients are more likely to experience temporary urinary retention after the procedure, need repeat treatment, or develop ejaculatory changes. Standardized criteria for defining overall treatment success are also lacking. The MISTER study is a multicenter registry designed to evaluate real-world outcomes of Rezūm therapy in patients treated in the Russian Federation. Using data from a large patient cohort, the study aims to identify factors associated with urinary retention after catheter removal, the need for repeat treatment or return to medication, and changes in ejaculatory function. The study will also develop and test combined criteria for defining treatment success.
Interventions
PROCEDURERezūm
Rezūm therapy is performed transurethrally by specialists at the study centers in accordance with established clinical practice. The type of anesthesia, the number and location of water vapor injections, treatment of the median lobe, characteristics of the indwelling catheter, and duration of catheterization were determined by the attending physician.
Sponsors
Sechenov University
Russian University of Medicine
N. I. Pirogov Clinic of High Medical Technologies
UGMK-Zdorovie Medical Center
SM-Clinic Multidisciplinary Medical Holding
MEDSI Group of Companies
URO-PRO Clinic
Avicenna Clinical Hospital
Neftyanik Medical and Sanitary Unit
St. Luke's Clinical Hospital
N. A. Semashko Railway Clinical Hospital ("RZD-Meditsina")
Liniya Zhizni LLC
S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
European Medical Center
RTH (Real Trans Hair) Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Lower urinary tract symptoms (IPSS ≥8 points; QoL ≥3 points) due to BPH * Prostate volume of 30-150 cm³ * Qmax ≤15 mL/s; post-void residual urine volume \<300 mL Non-Inclusion Criteria * Prostate cancer * Acute infections of the urinary tract, prostate, or scrotal organs * Neurogenic lower urinary tract dysfunction * Bladder stone(s) * Urethral stricture * Prior prostate surgery
Exclusion criteria
* Patient refusal to allow use of medical data for scientific analysis * Missing or lost data required for analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Rezūm therapy failure | 12 months | Rate of Rezūm therapy failure within 12 months after the intervention, defined as the occurrence of at least one of the following events: * Resumption or continuation of medical therapy for LUTS/BPH * Repeat surgical intervention for BPH * Failure to restore voiding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-void residual urine volume | 14 days | 14 days |
| International Prostate Symptom Score (IPSS) | 3, 6, and 12 months | Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35) |
| Qmax | 3, 6, and 12 months | — |
| Prostate volume | 3, 6, and 12 months | — |
| PSA level | 3, 6, and 12 months | — |
| International Index of Erectile Function (IIEF-5) | 3, 6, and 12 months | severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25) |
| Rate of de novo retrograde ejaculation | 3, 6, and 12 months | — |
Countries
Russia
Contacts
CONTACTVladislav Petov
Outcome results
None listed